Page 59 - Medicare Benefit Policy Manual

requirement when used for indications specified on the labeling. Therefore, the program
may pay for the use of an FDA approved drug or biological, if:

• It was injected on or after the date of the FDA’s approval;

• It is reasonable and necessary for the individual patient; and

• All other applicable coverage requirements are met.

The A/B MAC (A), (B), or (HHH), or DME MAC will deny coverage for drugs and
biologicals, which have not received final marketing approval by the FDA unless it
receives instructions from CMS to the contrary. For specific guidelines on coverage of
Group C cancer drugs, see the Medicare National Coverage Determinations Manual.

If there is reason to question whether the FDA has approved a drug or biological for
marketing, the MAC must obtain satisfactory evidence of FDA’s approval. Acceptable
evidence includes:

• A copy of the FDA’s letter to the drug’s manufacturer approving the new drug
application (NDA);

• A listing of the drug or biological in the FDA’s “Approved Drug Products” or
“FDA Drug and Device Product Approvals”;

• A copy of the manufacturer’s package insert, approved by the FDA as part of the
labeling of the drug, containing its recommended uses and dosage, as well as
possible adverse reactions and recommended precautions in using it; or

• Information from the FDA’s Web site.

When necessary, the regional office (RO) may be able to help in obtaining information.

50.4.2 - Unlabeled Use of Drug
(Rev. 1, 10-01-03)
B3-2049.3

An unlabeled use of a drug is a use that is not included as an indication on the drug’s
label as approved by the FDA. FDA approved drugs used for indications other than what
is indicated on the official label may be covered under Medicare if the A/B MAC (B)
determines the use to be medically accepted, taking into consideration the major drug
compendia, authoritative medical literature and/or accepted standards of medical practice.
In the case of drugs used in an anti-cancer chemotherapeutic regimen, unlabeled uses are
covered for a medically accepted indication as defined in §50.5.

These decisions are made by the MAC on a case-by-case basis.